The Senior Project Manager leads the technical and commercial execution of multiple client programs for sterile, unit-dose products manufactured by Blow-Fill-Seal (BFS) aseptic processing - from feasibility and technology transfer through registration batches, process validation, launch, and ongoing commercial supply. This customer- facing role is the primary point of contact for assigned clients and directs cross-functional teams across the site. It is the senior individual-contributor role within the Project Management Office and is positioned as a development role for progression into Project Management leadership: the incumbent is expected to mentor project managers, act as designee for the Director of Project Management, and take an increasing share of portfolio-level and PMO governance responsibility.
Key Responsibilities:
- Lead assigned client programs end to end for sterile BFS products - feasibility, quotation support, technology transfer, engineering and registration/exhibit batches, process validation (PPQ), stability, launch, and commercial supply.
- Serve as the primary customer contact and own the relationship at both working and executive level, including project review meetings, business reviews, and joint steering committees.
- Develop and maintain integrated project schedules, critical-path and resource analyses, risk registers, and milestone tracking tools. Report any variance as soon as it is recognized, together with a recovery plan.
- Direct cross-functional teams - Product Development, Analytical Services, Quality, Operations, Engineering, Supply Chain, Regulatory Affairs, and Finance - without direct reporting authority.
- Own project scope and change control: identify out-of-scope work, develop and negotiate change orders, and support quoting, revenue forecasting, and cash-flow phasing with Finance.
- Coordinate regulatory deliverables with Regulatory Affairs in support of ANDA, NDA/505(b)(2), and post-approval submissions, including customer data packages and response timelines.
- Represent Project Management in customer audits, technical visits, and regulatory inspections; coordinate cross-functional responses to customer technical queries and audit observations.
- Mentor and provide day-to-day direction to Project Managers, Associate Project Managers, and Project Coordinators, including review of their project plans and customer-facing deliverables.
- Serve as designee for the Director of Project Management as assigned, including portfolio reporting to site leadership and representation in leadership and governance meetings.
- Advance PMO capability - stage-gate standards, templates, project KPIs and dashboards, and lessons- learned reviews at program close.
- Establish and maintain internal and external meeting agendas and minutes as the controlled record of project decisions.
Qualifications:
- Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related field.
- Minimum 5-7 years of pharmaceutical, biotech, or CDMO experience, including at least 3 years directly managing projects.
- Sterile/aseptic manufacturing experience is preferred. Blow-Fill-Seal, sterile injectable, ophthalmic, or inhalation unit-dose experience is strongly preferred.
- Demonstrated ownership of at least one product through technology transfer and process validation into commercial supply.
- Direct external customer-facing experience in a contract development and manufacturing environment.
- Working knowledge of cGMP (21 CFR 210/211), FDA, EMA, ICH, and EU GMP Annex 1 requirements.
- PMP certification preferred; Lean Six Sigma a plus.
- Experience mentoring or leading project managers, or demonstrated readiness to progress into a people- leadership role.
Required Skills & Competencies:
- Strong customer relationship management, including the ability to hold a defensible technical positionwith a client while protecting the relationship.
- Excellent written and verbal communication; able to present credibly to both customer and Ritedose executive leadership.
- Financial fluency - project budgets, change orders, capital versus expense, and the revenue impact ofschedule movement.
- Technical judgment in aseptic processing, validation, and analytical/stability requirements sufficient to challenge and defend proposed timelines.
- Proficiency with project scheduling tools (MS Project, Smartsheet, or equivalent) and with electronic QMSand ERP systems.
- Leadership presence and the ability to influence without authority across a matrixed organization.
- Discretion in handling confidential customer information and competing client interests.
Work Environment & Physical Requirements:
- On-site position in Columbia, SC, with regular presence required in manufacturing and laboratory areas.
- Must be able to gown for and enter classified/controlled areas and comply with GMP dress code and site EHS requirements.